Non-obstructive Coronary Artery DiseaseEndoFINDNCT04013204
Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease
A study testing Endothelial function guided therapy in people with Non-obstructive Coronary Artery Disease, run by Peking University at 1 site in China.
Trial summary
The purpose of this study is to systematically evaluate the clinical application value of vascular endothelial function examination in patients with non-obstructive coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-obstructive Coronary Artery Disease
- What is being tested?
- Endothelial function guided therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2019to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: 18 years or older;
- 2. Patients with NOCAD defined by CT or CAG results of less than 50% occlusion;
- 3. Having signed their written informed consent.
Who cannot join
- 1. Left ventricular ejection fraction ≤ 50%;
- 2. Serious endocrine diseases (severe hyperthyroidism, hypothyroidism);
- 3. Severe liver diseases (jaundice hepatitis, liver cirrhosis, liver failure);
- 4. Severe nephropathy (uremia, renal failure);
- 5. Severe inflammatory diseases (severe infection, lupus erythematosus, etc.);
- 6. Malignant tumor;
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- 7. Mental disorders or cognitive disorders;
- 8. Participating in other interventional clinical trials;
- 9. There are any other factors that the treating doctors think are not suitable for inclusion or completion of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Shougang Hospital
Beijing
Hongyu Wang, MD, 13910906891, dr.hongyuwang@foxmail.com
Hongyu Wang, MD
About this study
Official title: Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND Study)
The purpose of this study is to systematically evaluate the clinical application value of vascular endothelial function examination in patients with non-obstructive coronary artery disease.
Read the detailed description
The study will be carried out in two stages. Phase I is mainly intended to evaluate the effects of vascular EFT on the prescription of doctors and the application rate of mid and long-term secondary prevention medication in patients. If the results are positive, the sample size and observation time will be further expanded in Phase II to evaluate its impact on the cardiovascular events of patients, as well as its cost-effectiveness.
- Conditions
- Non-obstructive Coronary Artery Disease
- Being tested
- Endothelial function guided therapy
- Keywords
- non invasive endothelial function test, non-obstructive coronary artery disease, Major Adverse Cardiovascular Events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial function guided therapyOther
To evaluate the effect of integration of non invasive endothelial function test (EFT) as a routine test in increasing appropriate treatment to reduce cardiovascular risk including prescription of lipid, blood pressure and glucose lowering medications by physicians at the clinic for patients with non-obstructive coronary artery disease (NOCAD) and the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with non-obstructive coronary artery disease(NOCAD).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group: Before the patient returns to the doctor and the prescription is issued, the EDCM system will feed back the EndoPAT test results to the responsible doctor through the automatically generated information on the doctor's mobile phone, but will not let the patient know the endothelium test results (blinded to the patient). Receives: Other: Endothelial function guided therapy |
| Control group | No intervention | Control group: The EDCM system will not report the EndoPAT test results to the responsible doctor (the doctor cannot see the final EFT results), nor can the patients know the EFT results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate of patients to physicians prescription
The incidence number of patients compliance to guidelines based medical therapy with prescription of cholesterol, blood pressure and glucose lowering medications by physicians at clinic for patients with non-obstructive coronary artery disease.
Measured: up to 30 months
Total incidence number of Major Adverse Cardiovascular Events
The incidence number of MACE(Major Adverse Cardiovascular Events) including total death, non-fatal AMI or stroke(including stroke revascularization).
Measured: up to 54 months
Secondary outcomes (8)
Mean improvement of endothelial function
The mean improvement in endothelial function from baseline to 12 months, estimated by RHI(Reactive Hyperemia Index).
Measured: up to 30 months
Incidence number of Major Adverse Cardiovascular Events
The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months
Measured: up to 30 months
Reduction of lipid levels
The reduction in lipid levels from baseline to 12 months
Measured: up to 30 months
Reduction of blood pressure
The reduction in blood pressure from baseline to 12 months
Measured: up to 30 months
Compliance rate of patients with treatment target
The percentage of patients with treatment target attained in terms of hypertension, diabetes, and dyslipidemia at 12 months after baseline.
Measured: up to 30 months
Compliance rate of patients with appropriate prescription by physicians
The percentage of patients with appropriate prescription of cholesterol, blood pressure and glucose lowering medications by physicians at 3, 6 and 12 months after baseline.
Measured: up to 30 months
Compliance rate of patients with healthy life style
The percentage of patients with healthy life style at 3, 6 and 12 months after baseline. The healthy life style is defined as having no smoking, physical activities with at least 3 times a week and 30 min per time, BMI<25 Kg/M2.
Measured: up to 30 months
Cost-effectiveness rate of Endothelial Function Testing
The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .
Measured: up to 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start15 Aug 2019
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-obstructive Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, patient and assessor blinded, parallel control, two-stage, clinical trial. Phase I: a feasibility study to collect data on key process outcomes including physician's prescription behaviors, patients' cardiovascular risk, and trend of reduction in cardiovascular events, To create an initial and to inform for the Phase II larger multicenter trial on choosing clinical endpoints and sample size. Phase II: will extend all patients from Phase I to a longer period of follow up and recruit more new patients to enlarge the sample size, in order to have a full study on the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with NOCAD.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Peking University Shougang Hospital
- Responsible party
- Principal investigator, Wang Hongyu, Peking University
- Investigators
- Hongyu Wang, MD, Principal investigator, Peking UniversityGaoqiang Xie, PHD, Study director, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013204
- Sponsor's protocol ID
- PUCRI-2019- EndoFIND-01
- Acronym
- EndoFIND
- Status last verified
- Mar 2021
- First submitted
- 1 Jul 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hwang IC, Jeon JY, Kim Y, Kim HM, Yoon YE, Lee SP, Kim HK, Sohn DW, Sung J, Kim YJ. Association between Aspirin Therapy and Clinical Outcomes in Patients with Non-Obstructive Coronary Artery Disease: A Cohort Study. PLoS One. 2015 Jun 2;10(6):e0129584. doi: 10.1371/journal.pone.0129584. eCollection 2015.
PubMed 26035823
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND Study)
- ClinicalTrials.gov ID
- NCT04013204
- Acronym / sponsor ID
- EndoFIND / PUCRI-2019- EndoFIND-01
- Conditions
- Non-obstructive Coronary Artery Disease
- Keywords
- non invasive endothelial function test, non-obstructive coronary artery disease, Major Adverse Cardiovascular Events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic, Peking University Shougang Hospital
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to systematically evaluate the clinical application value of vascular endothelial function examination in patients with non-obstructive coronary artery disease.
Detailed description
The study will be carried out in two stages. Phase I is mainly intended to evaluate the effects of vascular EFT on the prescription of doctors and the application rate of mid and long-term secondary prevention medication in patients. If the results are positive, the sample size and observation time will be further expanded in Phase II to evaluate its impact on the cardiovascular events of patients, as well as its cost-effectiveness.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, randomized, patient and assessor blinded, parallel control, two-stage, clinical trial. Phase I: a feasibility study to collect data on key process outcomes including physician's prescription behaviors, patients' cardiovascular risk, and trend of reduction in cardiovascular events, To create an initial and to inform for the Phase II larger multicenter trial on choosing clinical endpoints and sample size. Phase II: will extend all patients from Phase I to a longer period of follow up and recruit more new patients to enlarge the sample size, in order to have a full study on the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with NOCAD.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Endothelial function guided therapyIntervention group: Before the patient returns to the doctor and the prescription is issued, the EDCM system will feed back the EndoPAT test results to the responsible doctor through the automatically generated information on the doctor's mobile phone, but will not let the patient know the endothelium test results (blinded to the patient). |
| Control group | No intervention | –Control group: The EDCM system will not report the EndoPAT test results to the responsible doctor (the doctor cannot see the final EFT results), nor can the patients know the EFT results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Age: 18 years or older;
- 2. Patients with NOCAD defined by CT or CAG results of less than 50% occlusion;
- 3. Having signed their written informed consent.
Key exclusion criteria (9 listed)
- 1. Left ventricular ejection fraction ≤ 50%;
- 2. Serious endocrine diseases (severe hyperthyroidism, hypothyroidism);
- 3. Severe liver diseases (jaundice hepatitis, liver cirrhosis, liver failure);
- 4. Severe nephropathy (uremia, renal failure);
- 5. Severe inflammatory diseases (severe infection, lupus erythematosus, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endothelial function guided therapyTo evaluate the effect of integration of non invasive endothelial function test (EFT) as a routine test in increasing appropriate treatment to reduce cardiovascular risk including prescription of lipid, blood pressure and glucose lowering medications by physicians at the clinic for patients with non-obstructive coronary artery disease (NOCAD) and the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with non-obstructive coronary artery disease(NOCAD). | Other | Intervention group |
Primary outcome
Compliance rate of patients to physicians prescription
Time frame: up to 30 months
The incidence number of patients compliance to guidelines based medical therapy with prescription of cholesterol, blood pressure and glucose lowering medications by physicians at clinic for patients with non-obstructive coronary artery disease.
Total incidence number of Major Adverse Cardiovascular Events
Time frame: up to 54 months
The incidence number of MACE(Major Adverse Cardiovascular Events) including total death, non-fatal AMI or stroke(including stroke revascularization).
8 secondary outcomes
Mean improvement of endothelial function
Time frame: up to 30 months
Incidence number of Major Adverse Cardiovascular Events
Time frame: up to 30 months
Reduction of lipid levels
Time frame: up to 30 months
Reduction of blood pressure
Time frame: up to 30 months
Compliance rate of patients with treatment target
Time frame: up to 30 months
Compliance rate of patients with appropriate prescription by physicians
Time frame: up to 30 months
Compliance rate of patients with healthy life style
Time frame: up to 30 months
Cost-effectiveness rate of Endothelial Function Testing
Time frame: up to 54 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 26035823Hwang IC, Jeon JY, Kim Y, Kim HM, Yoon YE, Lee SP, Kim HK, Sohn DW, Sung J, Kim YJ. Association between Aspirin Therapy and Clinical Outcomes in Patients with Non-Obstructive Coronary Artery Disease: A Cohort Study. PLoS One. 2015 Jun 2;10(6):e0129584. doi: 10.1371/journal.pone.0129584. eCollection 2015.
- Li Zhennan, Lv Bin, Wang Zhiqiang, Liu Kun, Hou Zhihui, Gao Yang, Yin Weihua, Ren Xinshuang, Jiang Shiliang, Dai Ruping. The effect of coronary CT angiography on coronary heart disease prevention strategies. Natl Med J China, 2015;95:2664-7.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongyu Wang, MD principal investigator
Peking University
Gaoqiang Xie, PHD study director
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endothelial function guided therapy in people with Non-obstructive Coronary Artery Disease, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huan LIU, MSc (15650783607, liuhuan07@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate of patients to physicians prescription (time frame: up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.